盐酸二甲双胍达格列净缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.653999854399775340032883998067400319140004310.07
29.784026198402839240272950.04
单位质量响应值RSD%判断
414552.44411788.850.48数据可信
加速3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批113036831303758130372031.5531.362.8230.43%～32.28%
213331031334464133378432.28
312784311277427127792930.93
413290281329135132908232.17
512945651293483129402431.32
612344831235352123491829.89
2025081921批124451542445701244542859.1959.123.5656.92%～61.33%
224642852463277246378159.63
323996592398486239907258.07
425861912584297258524462.57
524441802443705244394259.15
623187992320191231949556.14
2025081922批139092293908506390886894.6194.901.8293.09%～96.70%
239569223960008395846595.81
338640863865415386475093.54
440422284048644404543697.91
538911173889601389035994.16
638573973855345385637193.34
盐酸二甲双胍达格列净缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.654029859403537840352644032942403508040337050.06
29.784020516402539240229540.09
单位质量响应值RSD%判断
418000.52411344.991.14数据可信
加速3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批113026371303917130327731.4332.251.5431.73%～32.77%
213380501338973133851232.28
313370751337690133738232.25
413319581331179133156832.11
513662001365804136600232.94
613465681347735134715232.49
2025081921批124436402448366244600358.9959.341.1158.65%～60.02%
224224342419330242088258.38
324669072469363246813559.52
424863152471106247871059.78
524500752451097245058659.10
624983302497560249794560.24
2025081922批138383153841359383983792.6194.681.3993.30%～96.05%
239332173933009393311394.85
338914303893719389257493.88
439483273953042395068495.28
539997433999114399942896.45
639367913940798393879494.99
盐酸二甲双胍达格列净缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.653979235398102139822453981902398355439815910.05
29.784019737402009740199170.01
单位质量响应值RSD%判断
412600.10411034.460.27数据可信
加速3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批111954861199965119772629.0832.335.2130.56%～34.10%
213405131341387134095032.56
313676921365809136675033.19
413875601391158138935933.74
513660341370504136826933.23
613245441325279132491232.17
2025081921批124701722346782240847758.4860.301.9459.08%～61.53%
224693402471782247056159.99
324830082482138248257360.28
425527342557745255524062.05
525063712505713250604260.85
624772362479389247831260.18
2025081922批138978323900521389917694.6896.251.0795.18%～97.32%
239466423943110394487695.79
340208724020119402049697.63
439937633994881399432296.99
539674753974668397107296.43
639498133956100395295695.99
盐酸二甲双胍达格列净缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.654072971403854640301984056269403348840462940.45
29.784089866408158240857240.15
单位质量响应值RSD%判断
419305.08417763.190.27数据可信
加速3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批113223041329514132590931.6831.841.3431.39%～32.29%
213197231323807132176531.58
313749031360451136767732.68
413205961318643131962031.53
513293021333966133163431.82
613280861329242132866431.75
2025081921批124926992490177249143859.5359.981.2259.21%～60.74%
225476992543231254546560.82
325454282546084254575660.83
424735322472322247292759.09
525180882512951251552060.10
624941442486206249017559.50
2025081922批140198064017251401852896.0195.630.3395.30%～95.96%
239791353979601397936895.08
340101914008333400926295.79
440051853993343399926495.55
540006744004900400278795.64
640075424004082400581295.71
盐酸二甲双胍达格列净缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.654106198408364440849384090696408896440908880.23
29.784098335410260241004680.08
单位质量响应值RSD%判断
423926.22419270.760.79数据可信
加速3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批113472391348242134774031.9731.711.8631.09%～32.33%
213146361315896131526631.20
313271461322567132485631.43
413394801338548133901431.76
513821681377476137982232.73
613141881314464131432631.18
2025081921批124570972459288245819258.3158.871.6257.87%～59.86%
224869202475843248138258.86
324540762462561245831858.31
424754882475224247535658.72
525564972564637256056760.74
624556022457650245662658.27
2025081922批139562463961713395898093.9193.043.3489.79%～96.30%
239735383976596397506794.29
339903003983720398701094.57
439494993951696395059893.71
540025404006558400454994.99
636565713660274365842286.78
盐酸二甲双胍达格列净缓释片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.654046903405368640287214054475405673540481040.29
29.784196371418232841893500.24
单位质量响应值RSD%判断
419492.64428358.901.48数据可信
加速3月-供试品溶液-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025081821批113689571345281135711932.0231.681.2331.27%～32.09%
213501611351265135071331.87
313385631340924133974431.61
413168831319879131838131.10
513295841331151133036831.39
613572951364145136072032.10
2025081921批124742992467711247100558.2959.581.5358.63%～60.54%
225552822553881255458260.27
325441592541246254270259.99
425088712507687250827959.17
525037652502127250294659.05
626099102539429257467060.74
2025081922批139920863993760399292394.2095.221.0494.19%～96.25%
241137944100949410737296.90
340610174058834405992695.78
440329304031443403218695.13
540060534014887401047094.61
640119744015854401391494.69
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